Downrampers Fail, page-7

it is difficult for me to imagine documentation is not yet by now in order that would lead to rejection of so CE marking should be un fait accompli. But if only we have not been told the straight story would there be difficulty. The words " insulin-like growth factor-i (igf-i) segment)" are to me of worry because if it is safety concerns on which TIS is being questioned - and igf-i is of important safety concern - then TIS may be demanded of to produce safety data. If management has not disclosed this and is attempting to use reference data to obtain marking then there could be delays. My interpretation of the technology is of using victronectin scaffold as the 'device' to deliver a biological agent. If the agent is inert or inactive or demonstrated safe drug, then no problem. But if an active pharmaceutical like igf to being delivered then this could be very complicating.